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Completed

NCT Number: NCT05107141

Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft

The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, over 18 years old.
  • In need of removal of a maxillary or mandibular molar first or second molar.
  • The molars to be extracted had to be bordered by at least one tooth.
  • The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
  • A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
  • Only one extraction per patient was accepted.

Exclusion criteria

  • Acute periodontal or periapical infection.
  • Pregnancy or lactancy.
  • Smokers of more than 10 cigarettes per day.
  • Previous adverse reactions to the biomaterials used in the study.
  • Metabolic diseases affecting the mechanism of bone remodelling.
  • Medications or treatments taken in the last twelve months and known to affect bone "turnover".
  • Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
  • Patients with absence of periodontal health maintenance or postoperative recommendations compliance.

Treatment and study plan

Ridge Preservation

Procedure

Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane

bone graft plus a collagen membrane

Device

Primary outcomes

  1. Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.

    Time frame: 5 months

    To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O&O (Denstply Sirona, Charlotte, NC, USA).

    Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest.

    The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.

Secondary outcomes

  1. Evaluate the influence of buccal or lingual bone thickness on bone ridge changes

    Time frame: 5 months

    The width of the buccal and lingual bone plates was evaluated, by CBCT analysis, at 1mm, 3mm and 5mm to evaluate any correlation with bone dimensional changes after 5 months.

    Data was expressed in milimeters.

  2. Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.

    Time frame: 5 months

    The histomorphometric analysis was performed by the use of a specific software image (Image J®, Image Processing and Analysis in Java) and the areas occupied by vital bone (VB), non-mineralized connective tissue (NMCT) and graft particles (GP) were evaluated. The analysis of each tissue volume was expressed in percentages (%)

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

  • BioHorizons, Inc.
  • Dentsply Sirona Implants and Consumables
  • Geistlich Pharma AG

Registry information

Official study title

Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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